A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 Administered Orally to Patients With Sickle Cell Disease

Trial Profile

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 Administered Orally to Patients With Sickle Cell Disease

Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2018

At a glance

  • Drugs Voxelotor (Primary)
  • Indications Sickle cell anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms GBT-HOPE; HOPE
  • Sponsors Global Blood Therapeutics
  • Most Recent Events

    • 27 Jun 2018 According to the Global Blood Therapeutics media release, based on the positive Part A results and ongoing regulatory discussions, GBT continues to dose Part A patients, plus approximately 100 additional patients across all three treatment arms, to gather more data. At this time, GBT does not plan additional enrollment until it completes discussions with the FDA.
    • 27 Jun 2018 Primary endpoint (Change in hemoglobin (Hb) at 1500 mg and 900 mg dose of voxelotor) has been met.
    • 27 Jun 2018 According to the Global Blood Therapeutics media release, plans to present results from Part A at a medical meeting later this year.
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